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Miracles In Sight Lone Star Division FDA Inspection Record

FEI 3001238012 · Inspections, Form 483s, warning letters and import refusals

Miracles In Sight Lone Star Division is an FDA-inspected facility (FEI 3001238012) located in Manor, TX, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Mar 10, 2023: No Action Indicated (NAI)
Inspections on record
6 (1 OAI, 1 VAI, 4 NAI)
Last OAI inspection
Jul 25, 2011
Warning letters
1 listed by FDA for this FEI, latest Dec 9, 2011
Recalls as the recalling firm
4, latest Aug 25, 2004

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 10, 2023No Action Indicated (NAI)No citations listed
Aug 9, 2018No Action Indicated (NAI)No citations listed
Apr 18, 2014No Action Indicated (NAI)No citations listed
May 1, 2012No Action Indicated (NAI)No citations listed
Jul 25, 2011Official Action Indicated (OAI)Ten year retention (21 CFR 1271.55(d)(4))
Cleaned, sanitized per established schedules (21 CFR 1271.200(a))
Storage temperatures recorded, maintained (21 CFR 1271.260(e))
Periodic review of temperatures (21 CFR 1271.260(e))
Oct 7, 2009Voluntary Action Indicated (VAI)Procedures inadequate (21 CFR 1271.200(b))
Retention time (10 year rules) (21 CFR 1271.270(d))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 25, 2004Class IIB-0361-5Human Corneal Tissue
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeated…
Jan 6, 2004Class IIB-0911-4Human Cornea Tissue
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly…
Dec 4, 2003Class IIB-1931-4Human Tissue for Transplantation, Corneas
Human tissue for transplantation, that tested reactive for antibodies to hepatitis B core antigen (anti-HBc), was distributed.
Aug 5, 2002Class IIB-0936-3Human Tissues for Transplantation Corneas
Corneas, collected from a donor who had dura mater transplantation, were distributed.

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

7 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsDec 9, 201110 years or older, so it adds no points0
Inspection classified OAIJul 25, 201110 years or older, so it adds no points0
Inspection classified VAIOct 7, 200910 years or older, so it adds no points0
Class II recall B-0361-5, this FEI as the recalling firmAug 25, 200410 years or older, so it adds no points0
Class II recall B-0911-4, this FEI as the recalling firmJan 6, 200410 years or older, so it adds no points0
Class II recall B-1931-4, this FEI as the recalling firmDec 4, 200310 years or older, so it adds no points0
Class II recall B-0936-3, this FEI as the recalling firmAug 5, 200210 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Miracles In Sight Lone Star Division
Location
Manor, TX (US)
Source
inspections

Compliance actions

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.